Planning a Health Canada PRCI Compliant Submission Blog Post
How to set yourself up for a successful Health Canada PRCI submission
Part 2: Oligonucleotide therapeutic development: Pre-clinical and translational considerations Blog Post
In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth…
Plan to Accelerate Your Time to Drug Submissions Blog Post
There are common themes driving how quickly you can get from your last database lock (DBL) to submission of your marketing application. Speaking from first-hand experience across more than 50…
A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development Blog Post
Pediatric PBPK models have broad application in the drug development process and are being used increasingly to optimise and replace clinical studies. However, the approach has yet to become fully…
Overcome Research Hurdles: Expert Guidance for Complex Generic Drug Development Blog Post
Do expensive bioequivalence studies stall your generic drug approval? Learn how you can streamline complex generic drug development with our white paper.
Predicting the Effect of the Dulaglutide-Mediated Gastric Emptying Delay on Drug Exposure Blog Post
The European Medicines Agency (EMA) recently approved dulaglutide (Trulicity®) at higher doses (3 mg and 4 mg solutions). Dulaglutide is indicated for the treatment of adults with insufficiently controlled type…
Document Quality and Management Page
Certara’s regulatory document quality and management services help sponsors ensure accuracy, compliance, and efficiency in their regulatory submissions.
Legislators: Bring all stakeholders to the table to lower drug costs Blog Post
BY ROMAN CASCIANO, OPINION CONTRIBUTOR — 03/29/21 05:30 PM EDT No one is happy with the price of drugs nor how we pay for them: not patients, not the lawmakers who…
Strategic Evidence & Value Communication Symposium Blog Post
Join us on Wednesday, April 21, 2021, from12:00 PM – 2:00 PM EDT for Certara’s first annual Strategic Evidence & Value Communication Symposium. Across two panel discussions, a host of Certara and industry experts will debate and explore various best practices to ensure effective communication of product value, as well as the expanded use of Real World Evidence to accelerate market access decision-making.
Purity is a Virtue: A Practical Guide to the Reporting of Impurities Blog Post
Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and how to include them in their regulatory applications. This webinar is designed to increase the…
